1. RCT RESEARCH QUESTION:
Is it feasible to enroll newly mechanically ventilated adults in a multi-centre pilot RCT of early in-bed cycling plus routine physiotherapy versus routine physiotherapy alone to inform a larger RCT?

2. Rationale for CYCLE
Patients developing muscle weakness in the ICU are at a higher risk of death and disability
Muscle weakness begins within the 1st 7 days of bed rest
Exercise started within 1.5 days of mechanical ventilation improved patients’ function at hospital discharge
Cycling started 2 weeks after ICU admission improved patients’ 6-minute walk at hospital discharge
Can cycling start earlier in a patient’s ICU stay and will it improve patients’ function at hospital discharge?

3. E-CYCLE Pilot RCT Main Inclusion and Exclusion Criteria
Inclusion Criteria
Exclusion Criteria
Adults > 18 years old
Invasively mechanically ventilated < 4 days
Expected additional 2 day ICU stay
Ambulated independently (with or without gait aid) pre-hospital
ICU LOS < 7 days
Unable to follow simple commands in English at baseline
Acute condition impairing ability to cycle (e.g., leg fracture)
Proven or suspected neuromuscular weakness affecting the legs (e.g., stroke, Guillain Barre)
Temporary pacemaker
Patient unable to fit bike
Palliative goals of care
Pregnancy
Cycling exemption not resolved during 1st 4 days of MV

4. Cycling / Routine PT Exemptions
Any increase in vasopressor/ inotrope (2 h)
Active MI, or unstable/ uncontrolled arrhythmia per ICU team
MAP <60 or >110 mmHg or out of range for this patient (2 h)
Heart Rate <40 or >140 bpm (2 h)
Persistent SpO2 <88% or out of range for this patient (2h)
Neuromuscular blocker (4 h)
Severe agitation (RASS>2 [or equivalent]) (2 h)
Uncontrolled pain
Change in goals to palliative care
Team perception that in-bed cycling or therapy is not appropriate despite absence of above criteria

5. RCT Study Schema ICU Admission Randomized @ Study Entry ≤4 d MV
Awake
ICU Discharge
Test #2
3 d Post-ICU Discharge
Test #3
Hospital Discharge
Test #4
30 min cycling + Routine PT or Routine PT
Routine PT
Clinical Course
Intubated
Study Outcome Assessments
Test #1
-We would enroll patients within the first 4 days of MV, and offer cycling and routine pt or routine PT alone during the patient’s ICU stay
-Goal to bike patients as early as possible
-Awakening – PTs assess daily – MRC strength (6 muscles bilaterally); PFIT – physical function test for ICU – shoulder and knee extensor strength, sit to stand, marching on the spot
-re-start cycling within 72 hours if re-admitted
Intervention: 30 minutes cycling + routine PT or routine PT alone during their ICU stay (5 d/ week, excluding statutory holidays, maximum 28 days)
Once a patient can march on the spot, cycling in the ICU will be discontinued
Assessments: Strength and function tests at ICU awakening, ICU discharge, 3 days post-ICU discharge & Hospital discharge

6. Questions? Contact: Michelle Kho, PT, PhD (289) 237-0194
Alex Molloy, (289)
France Clarke, RRT (905) Ext
Deborah Cook, MD, MSc
Jill Rudkowski, MD
Thank you!
This study is approved by the Hamilton Integrated Research Ethics Board HIREB